I want to check if I'm eligible for PECAN (Prise en Charge Anticipée Numérique).
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Does my DMN have a therapeutic purpose or is it a telemonitoring activity?
What is a therapeutic digital MD?
- Any digital DM that aims to treat, cure a pathology or relieve the symptoms of a disease.
- This does not include: digital DMs that relate to prevention, diagnosis, disability compensation, prognosis or prediction.
What is atelemonitoring solution?
It's the combination of:
- Medical monitoring carried out remotely by a medical professional or team on the basis of data transmitted by the patient.
- The patient's use of a digital telemonitoring medical device.
Find out more: see our page on telemonitoring
Has my product been CE marked for medical devices?
To be marketed in the EU, my DMN must meet general safety and performance requirements. These are defined in the European DM regulations.
Find out more: visit My CE mark.
Is my solution innovative?
The argument demonstrating the "innovative" nature of your solution is to be developed. It is evaluated by the CNEDiMTS.
The solution must be presumed innovative in terms of clinical benefits or organizational progress. This assessment is the exclusive responsibility of the Commission and is based on the first available data and taking into account any relevant comparators.
Can I demonstrate the clinical and/or organizational benefits of my solution?
My DMN must present presumed innovative characteristics, in terms of clinical and/or organizational benefits.
The evaluation of my DMN's interest is based on convincing clinical studies, which may be of varied nature depending on the expected service sought.
Check out the 7 good questions to ask yourself.
Can my DM or remote monitoring activity export processed data?
- It enables data to be exported in appropriate, interoperable formats or nomenclature, guaranteeing direct access to the data.
- Or it includes interfaces enabling data exchange with devices or accessories for collecting patient vital parameters.
My solution is already covered by another plan
I'm eligible for PECAN (Prise en Charge Anticipée Numérique)
Early reimbursability is relevant to you
Go to my PECAN roadmap